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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06537817




Registration number
NCT06537817
Ethics application status
Date submitted
30/07/2024
Date registered
5/08/2024

Titles & IDs
Public title
Study to Evaluate HT-4253 in Healthy Subjects
Scientific title
A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) of Oral HT-4253 in Healthy Adults
Secondary ID [1] 0 0
HT-4253-NHV-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HT-4253
Treatment: Drugs - Placebo

Experimental: HT-4253 - Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 6 subjects will receive HT-4253.

Placebo comparator: Placebo to match HT-4253 - Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 2 subjects will receive matching placebo.


Treatment: Drugs: HT-4253
HT-4253 Single or Multiple doses administered orally as a tablet

Treatment: Drugs: Placebo
Placebo to match HT-4253 Single or Multiple doses administered orally as a tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [1] 0 0
up to 6 weeks
Primary outcome [2] 0 0
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [2] 0 0
up to 6 weeks
Primary outcome [3] 0 0
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [3] 0 0
up to 6 weeks
Primary outcome [4] 0 0
To evaluate the safety and tolerability of single and multiple ascending
Timepoint [4] 0 0
up to 6 weeks
Secondary outcome [1] 0 0
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [1] 0 0
up to 6 weeks
Secondary outcome [2] 0 0
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [2] 0 0
up to 6 weeks
Secondary outcome [3] 0 0
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [3] 0 0
up to 6 weeks
Secondary outcome [4] 0 0
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
Timepoint [4] 0 0
up to 6 weeks

Eligibility
Key inclusion criteria
* Age is = 18 years to 65 years
* Body mass index between 18 and 32 kg/m2
* Female subjects must be surgically sterile or post menopausal for at least 12 months. Females may be of child-bearing potential but must use double contraception.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions,
* History of suicidal behavior and/or ongoing suicidal ideation per C-SSRS evaluation when screening
* Use of any medications, including prescription, over-the-counter (OTC) medications, vitamins, herbal preparations, and supplements
* Positive drug screen or alcohol breath tests
* History of heavy smoking more than 10 cigarettes a day or the tobacco/nicotine equivalent within 3 months of Screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study
* Clinical significant abnormalities in laboratory test results
* Chronic or current active infectious disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Halia Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
385-355-4315
Fax 0 0
Email 0 0
monitor@haliatx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06537817